FDA Approval (Was outreach clinic in upstate NY)

[Guest guest]

Hmmm... I don't know. Maybe we should start a pool. I'm guessing by the time

my 4 year old has finished graduate school. So I'll take June 2023. Any

other takers?

Okay, I know this isn't really very funny when the future of so many

children are at stake. But the problem with the protocol is that only

children and their families will profit from FDA approval. Pharmaceutical

companies put a lot of money into lobbyists and backing so-called

third-party, objective *experts* to put pressure on the FDA to expedite the

approval process for their product. A lot of high-level politics and big

money goes into setting the FDA agenda.

Personally, I think one of the biggest obstacles to gaining political

advocacy for medical intervention is the lack of one national organization

that all parents would support. Many parents are only supportive of methods

(whether it is medical, diet or behavioral) that worked for their child. The

etiology of each child's autism is long, involved and complex--it's hard to

fully understand all aspects even when you are a concerned parent. It'll be

a long haul educating FDA officials, government leaders and the media to

make a paradigm shift in their understanding of autism.

Again, just my two or three cents.

Lynne

> Does any one have an idea when procedure would be approved by FDA in

> treatment of autism?

> Thanks

> S.M.

[Guest guest]

Another couple cents. The original question concerning when the "

Protocol " will be approved by FDA. There is nothing for them to approve.

The " Protocol " is a basically just the application of sound

immunological and other medical principals utilizing exisitng drugs. Any MD

can implement the basic ideas if they had enough

interest/motivation/education. If on the other hand you are talking about

the " phantom immune modulator " that Dr G has talked about, that is only one

drug in the arsenal and that has not even been thoroughly tested. I'll put

my bet down on the table for that one being available and FDA approved for

the unborn autistic children. As I understand (from an insider) the patent

has been in litigation for several years.

Ray

At 12:23 PM 7/31/02 -0700, you wrote:

>Hmmm... I don't know. Maybe we should start a pool. I'm guessing by the time

>my 4 year old has finished graduate school. So I'll take June 2023. Any

>other takers?

>

>Okay, I know this isn't really very funny when the future of so many

>children are at stake. But the problem with the protocol is that only

>children and their families will profit from FDA approval. Pharmaceutical

>companies put a lot of money into lobbyists and backing so-called

>third-party, objective *experts* to put pressure on the FDA to expedite the

>approval process for their product. A lot of high-level politics and big

>money goes into setting the FDA agenda.

>

>Personally, I think one of the biggest obstacles to gaining political

>advocacy for medical intervention is the lack of one national organization

>that all parents would support. Many parents are only supportive of methods

>(whether it is medical, diet or behavioral) that worked for their child. The

>etiology of each child's autism is long, involved and complex--it's hard to

>fully understand all aspects even when you are a concerned parent. It'll be

>a long haul educating FDA officials, government leaders and the media to

>make a paradigm shift in their understanding of autism.

>

>Again, just my two or three cents.

>

>Lynne

>

>> Does any one have an idea when procedure would be approved by FDA in

>> treatment of autism?

>> Thanks

>> S.M.

>

>

>

>Responsibility for the content of this message lies strictly with

>the original author, and is not necessarily endorsed by or the

>opinion of the Research Institute.

>

>

>

[Guest guest]

Ray, it's my understanding that any previous issues were cleared up quite

some time ago. That was on just one of the immune modulators. There are a

half dozen or so that could go into trials depending on the funding

available.

I have found some of the research on the immune modulator that you refer to

and it looks like it can do some amazing things without toxicity. I would

take it right now if I had access to it. We need the studies that prove

these kids are medical and so that everyone will have access to new

treatments for immune/autoimmune disorders.

I'm grateful that we have something that is helping our kids now (

protocol), but we need and want something that works in a much more direct

way.

Cheryl

>From: Ray Palmer <palmerr@...>

>Reply-

>

>Subject: Re: FDA Approval (Was outreach clinic in upstate NY)

>Date: Wed, 31 Jul 2002 15:28:34 -0500

>

>Another couple cents. The original question concerning when the "

>Protocol " will be approved by FDA. There is nothing for them to approve.

>The " Protocol " is a basically just the application of sound

>immunological and other medical principals utilizing exisitng drugs. Any MD

>can implement the basic ideas if they had enough

>interest/motivation/education. If on the other hand you are talking about

>the " phantom immune modulator " that Dr G has talked about, that is only one

>drug in the arsenal and that has not even been thoroughly tested. I'll put

>my bet down on the table for that one being available and FDA approved for

>the unborn autistic children. As I understand (from an insider) the patent

>has been in litigation for several years.

>Ray

>

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[Guest guest]

Lynn, well said - include the world here too!

Without being flippant - we can take a leaf out of the book on all our

collective knowledge on ABA or Koegels or even Floor Time approaches in

working with our kids in dealing with the medical/legislative bureaucracy -

break it down into small logical steps and take it to their level - and drip

feed it!

Think about it - Lynn's points below are very real - how can we expect to

appeal to people who do not have kids with this very complex disease and get

them to understand unless we break it into small parts!

RW

FDA Approval (Was outreach clinic in upstate NY)

Hmmm... I don't know. Maybe we should start a pool. I'm guessing by the time

my 4 year old has finished graduate school. So I'll take June 2023. Any

other takers?

Okay, I know this isn't really very funny when the future of so many

children are at stake. But the problem with the protocol is that only

children and their families will profit from FDA approval. Pharmaceutical

companies put a lot of money into lobbyists and backing so-called

third-party, objective *experts* to put pressure on the FDA to expedite the

approval process for their product. A lot of high-level politics and big

money goes into setting the FDA agenda.

Personally, I think one of the biggest obstacles to gaining political

advocacy for medical intervention is the lack of one national organization

that all parents would support. Many parents are only supportive of methods

(whether it is medical, diet or behavioral) that worked for their child. The

etiology of each child's autism is long, involved and complex--it's hard to

fully understand all aspects even when you are a concerned parent. It'll be

a long haul educating FDA officials, government leaders and the media to

make a paradigm shift in their understanding of autism.

Again, just my two or three cents.

Lynne

> Does any one have an idea when procedure would be approved by FDA in

> treatment of autism?

> Thanks

> S.M.

Responsibility for the content of this message lies strictly with

the original author, and is not necessarily endorsed by or the

opinion of the Research Institute.